Biopharmaceutical company Stemedica Cell Technologies Inc reported on Monday the receipt of the US Food and Drug Administration (FDA) investigational new drug (IND) approval for its Phase II clinical trial of intravenous allogeneic mesenchymal stem cells in COVID-19 patients.
The company said it will launch a "Phase II, multi-centre, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and preliminary efficacy of intravenous allogeneic mesenchymal stem cells in patients with moderate to severe lung injury due to COVID-19."
Under the Phase II placebo-controlled study, the company will enroll up to 40 patients into two cohorts, randomized 1:1 to receive the active study drug plus standard treatment or placebo (lactate ringer solution) plus standard treatment.
Prior to submission of an IND, about 14 critically ill COVID-19 patients were treated on emergency and expanded use INDs at the Providence Saint John's Health Center (Santa Monica, CA) and ProMedica (Toledo, OH). Within 24-48 hours of receiving the stem cells, all patients had a significant reduction in oxygen requirements. Several patients went from an inability to talk or eat due to shortness of breath to speaking in full sentences and eating full meals comfortably shortly after treatment. The study found improved inflammatory modulation.
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